About the Role
We are seeking a Process Engineer II to join our Manufacturing Operations team.
This is a full-time, on-site position focused on supporting GMP manufacturing activities and ensuring seamless integration within the existing team.
Key Responsibilities:
* Set up, execute, and troubleshoot upstream, downstream, and support unit operations in continuous and fed-batch manufacturing processes under GMP guidelines.
* Manage documentation for process execution, deviations, changes, and CAPAs while collaborating with Quality Assurance and other internal stakeholders.
* Contribute to continuous improvement initiatives and support the implementation of new technologies, including non-GMP engineering runs or testing activities.
* Create and update SOPs and electronic master batch records, as well as review technical documentation for process transfer and GMP manufacturing.
* Mentor and train junior team members and actively participate in knowledge transfer.
* Participate in sampling activities or be on-call, including potential weekend duties.
Requirements:
* Educational background in a relevant discipline.
* 2-5 years of experience in the pharmaceutical or biotech industry.
* Minimum of 2 years of practical experience in the GMP manufacturing of biologics (upstream or downstream).
* Expert knowledge in specific unit operations for biologics manufacturing.
* Understanding of GMP principles and the ability to work under pressure in a complex environment.
Preferred Skills and Experience:
* Bachelor's or Master's degree in a relevant discipline.
* Familiarity with quality management and compliance systems.
* Experience with automated systems or electronic batch records.
* Previous experience with process development or scale-up activities.
* Ability to work efficiently as part of a team and independently on projects.
Additional Information
Candidates must either live in the surrounding area or be willing to relocate near Schachen, Luzern.